In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Triniplas Drug Master File in Korea (Triniplas KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Triniplas. The MFDS reviews the Triniplas KDMF as part of the drug registration process and uses the information provided in the Triniplas KDMF to evaluate the safety and efficacy of the drug.
After submitting a Triniplas KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Triniplas API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Triniplas suppliers with KDMF on PharmaCompass.